三种检测系统测定血清C反应蛋白结果的一致性分析

A Consistency Analysis of Serum C-Reactive Protein Measured by Three Detection Systems

目的对三种检测系统测定血清C反应蛋白(CRP)的结果进行比对和相关性分析,评价不同检测系统测定血清CRP结果的一致性。方法参照美国临床医院标准化委员会(NCCLS)的EP9-A2文件的要求,收集40例浓度覆盖检测范围的血清标本,以罗氏Cobas c702全自动生化分析仪作为参考系统,贝克曼库尔特AU5800全自动生化分析仪和普门PA-990特定蛋白分析仪作为比对系统,计算线性回归方程及医学决定水平处的预期偏差及预期偏差的95%可信区间(CI),评估三种检测系统的一致性。结果贝克曼库尔特AU5800全自动生化分析仪、普门PA-990特定蛋白分析仪和罗氏Cobas c702全自动生化分析仪检测的CRP结果的相关性良好,R^(2)为0.9632~0.9810,经过回归方程的斜率和截距校正后,R^(2)为0.9910~0.9964,医学决定水平处的Bc在0.005~9.547之间。结论通过校正后,三种检测系统测定血清C反应蛋白(CRP)的检测结果具有可比性,适合临床应用。

Objective To evaluate the comparability of the results of serum CRP measured by three detection systems.Methods According to National Committee for Clinical Laboratory Standards(NCCLS)document EP9-A2,40 serum samples covering the detection range were collected for the study.Roche Cobas c702 automatic biochemical analyzer was used as a reference system,while Beckman Coulter AU5800 automatic biochemical analyzer and PA-990 specific protein analyzer were used as the comparison systems.The linear regression equation,the expected bias and 95%confidence interval at medical decided levels were calculated.The comparability of these three detection systems was evaluated.Results After corrections,the CRP results detected by Beckman Coulter AU5800 automatic biochemical analyzer and PA-990 specific protein analyzer had a good correlation with results of Roche Cobas c702 automatic biochemical analyzer,in which R^(2) range was 0.9632-0.9810.After corrections,R^(2) range was 0.9910-0.9964,and the expected deviation at the medically determined level were 0.005-9.547.Conclusion After corrections,the CRP results measured by three detection systems are comparable and suitable for clinical applications.